PICC NATE 1.9 FRENCH
Received Apr 19, 2022 · Event occurred Feb 16, 2022
Report 1718872-2022-00002 · MDR key 14148006
Device
Generic name
Introavascular Catheter
Manufacturer
Utah Medical Products Inc.Model number
N/ACatalog number
PC-2PS
Lot number
1202164
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
8 DA · Female
- Perforation of Vessels
- Perforation of Vessels
Narrative
Description of Event or Problem
THE PERPHERALLY INSERTED CENTRAL CATHETER (PICC) INFILTRATED. UPON FURTHER INVESTIGATION IT HAS BEEN DETERMINED THAT THERE HAVE BEEN A TOTAL OF THREE PATIENT CARE EVENTS RELATED TO THIS BRAND OF PICC LINE THAT RESULTED IN INFILTRATION OT THE NEONATE. THE DEVICES WERE FOUND TO BE FROM THE SAME LOT. THIS WAS DISCOVERED FROM A COMMON CAUSE ANALYSIS.
Additional Manufacturer Narrative
UTMD IS REPORTING THIS EVENT BECAUSE THE MEDICAL STAFF REPORTED THAT THE PICC INFILTRATED INTO THE PATIENT OUTSIDE OF THE VEIN DURING USE. THE HOSPITAL STAFF DID NOT IDENTIFY A FAULT WITH THE PICC, AND DID NOT DETERMINE WHAT CAUSED THE INFILTRATION. NO PERMANENT INJURY WAS REPORTED IN ALL THREE CASES. NO SIMILAR COMPLAINTS FOR ANY LOT HAVE BEEN REPORTED. DURING THE LAST THREE YEARS (LOOK-BACK PERIOD).